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CTRI Number  CTRI/2025/11/098172 [Registered on: 28/11/2025] Trial Registered Prospectively
Last Modified On: 26/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to evaluate the Effect of Ayurvedic Therapies with Ksheerabala Taila as an add on to Cognitive Behavioural Therapy for Insomnia in Perimenopausal Women 
Scientific Title of Study   Randomized Controlled Trial evaluating Ayurvedic therapies- Siro pichu and Padabhyanga with Ksirabala Taila as an Add on to Cognitive Behavioural Therapy-Insomnia (CBT-I) for the management of Insomnia in Perimenopausal Women 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Parvathy Unnikrishnan 
Designation  Associate Professor 
Affiliation  Amrita School of Ayurveda 
Address  Department of Prasoothi Tantra and Stree Roga Amrita School of Ayurveda Amritapuri Vallickavu Kollam
Amritapuri Vallickavu Kollam
Kollam
KERALA
690525
India 
Phone  9497882774  
Fax    
Email  dr.parvathy@ay.amrita.edu  
 
Details of Contact Person
Scientific Query  
Name  Parvathy Unnikrishnan 
Designation  Associate Professor 
Affiliation  Amrita School of Ayurveda 
Address  Department of Prasuthi tantra and Sthreeroga Amritapuri Vallickavu Kollam
Amritapuri, Vallickavu, Kollam
Kollam
KERALA
690525
India 
Phone  9497882774  
Fax    
Email  dr.parvathy@ay.amrita.edu  
 
Details of Contact Person
Public Query  
Name  Devipriya Soman 
Designation  Associate Professor 
Affiliation  Academic Institution 
Address  Department of kayachikitsa Amrita School of Ayurveda Amritapuri Kollam
Amrita School of Ayurveda Clappana PO Kollam
Kollam
KERALA
690525
India 
Phone  9495638076  
Fax    
Email  priya3656@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Amrita School of Ayurveda 
Address  Amritapuri, Kollam, Kerala, India 690525 
Type of Sponsor  Other [Academic Institution] 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Parvathy Unnikrishnan  Amrita Ayurveda Hospital  Department of Prasuti Tantra and Sthree Roga Clappana PO VAllikkavu Amritapuri Kollam 690525
Kollam
KERALA 		 9497882774

dr.parvathy@ay.amrita.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Amrita School of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F510||Insomnia not due to a substance orknown physiological condition. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-SiraHpicuH, शिरःपिचुः (Procedure Reference: Ashtanga Hridaya, Procedure details: Application of a sterile cotton pad soaked in Kṣirabala Taila placed on the vertex of the head for 30 minutes every night, approximately 1 hour before bedtime, for 7 consecutive days from the Day 1. )
2Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Ashtanga Hridaya, Procedure details: Gentle massage of each foot with Kṣirabala Taila for a minimum of 5 minutes per foot, performed twice daily morning and night for 14 consecutive days from Day 1.)
(1) Medicine Name: Kṣirabala Taila, Reference: Sahasrayogam, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Duration: 14 Days
3Comparator Arm (Non Ayurveda)-Cognitive Behavioural TherapyCBT I is delivered to all participants according to the study schedule two sessions per week over four weeks with a three months follow up.
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Women aged 45 to 55 years

Insomnia Severity Index(ISI ) score in between 8-21; identified by symptoms of difficulty initiating or maintaining sleep, or early morning awakening, occurring at least three nights per week, persisting for a minimum duration of three months, and associated with clinically significant distress or impairment in daytime functioning.

Able to understand and comply with CBT instructions.

Able to provide written informed consent.
 
 
ExclusionCriteria 
Details  Known cases of Hypertension, Thyroid disorders, and Diabetes Mellitus.
Those who require HRT during their menopausal period.
PHQ-9 Depression scale Score greater than 5.
Under medication for any psychological or psychiatric disorders & substance use in the past 30 days.
Any active medical or neurological conditions causing sleep disruption.
No access to mobile phones and internet.
Engagement in rotating shift work or any known lifestyle factors that disrupt normal sleep timing.
Use of sleep inducing medications, anti depressants, anti psychotics or sedatives in the past 30 days
BMI greater than 35
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in Insomnia Severity Index total score and Pittsburgh Sleep Quality Index score from baseline to end of intervention  Primary Outcome will be assessed at baseline and at four weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Early therapeutic response assessed using Insomnia Severity Index total score at Week 2; longitudinal change in Insomnia Severity Index total score during follow up at Weeks 6 8 10 and 12; change in Pittsburgh Sleep Quality Index score during follow up at Weeks 4 8 and 12; occurrence and characterization of clinically relevant events using validated adverse event and adverse drug reaction monitoring checklist; behavioural dependency risk assessed using Severity of Dependency Scale total score; treatment adherence and fidelity assessed using Daily Sleep and Treatment Engagement Diary  Week 2 Weeks 4 6 8 10 and 12 Baseline to Week 12 and daily during intervention 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   09/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.parvathy@ay.amrita.edu].

  6. For how long will this data be available start date provided 07-02-2027 and end date provided 07-12-2035?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The single centre parallel group randomized controlled trial is designed to evaluate the efficacy of Ayurvedic therapies Siro pichu and Padabhyanga with Ksirabala Taila as adjuncts to Cognitive Behavioural Therapy for Insomnia in the management of chronic insomnia among perimenopausal women aged 45 to 55 years. Insomnia affects nearly half of women during the menopausal transition and while CBT I is the recommended first line non pharmacological treatment it often requires 4 to 6 weeks for noticeable improvement leading to early discontinuation in up to 30 to 40 percent of patients. Ayurvedic therapies targeting Vata imbalance such as Siro pichu and Padabhyanga are traditionally used to induce relaxation and sleep with preclinical evidence suggesting effects on GABAergic modulation and parasympathetic activation. The trial will enroll eligible women with subthreshold to moderate insomnia after screening and informed consent. Participants will be randomized into two groups: the intervention group will receive CBT I along with Siro pichu for 30 minutes nightly for 7 days and Padabhyanga for twice daily for 14 days while the control group will receive CBT I alone. CBT I will be delivered to both groups through eight standardized sessions over four weeks, supplemented by sleep hygiene counselling. The primary outcomes are mean reduction in the Insomnia Severity Index and Pittsburgh Sleep Quality Index scores after four weeks. Secondary outcomes include early improvement in ISI scores at two weeks, sustained changes in ISI and PSQI during a three month follow up occurrence of adverse events and dependency risk assessed using the Severity of Dependency Scale, and adherence assessed by daily diaries. All Ayurvedic medicines will be sourced from a GMP certified manufacturer and administered under standard operating procedures. Safety will be closely monitored and rescue measures will be available if required. This academic trial, conducted at the Department of Prasuti Tantra and Stri Roga Amrita Ayurveda Hospital aims to generate evidence on whether integrating Ayurvedic therapies with CBT I can provide faster symptomatic relief enhance adherence and sustain sleep benefits without pharmacological risks in perimenopausal women with insomnia. 
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